CEMI - Chembio Diagnostics submits 510(k) request to FDA for DPP SARS-CoV-2 Antigen test

Chembio Diagnostics (NASDAQ:CEMI) has submitted a De Novo/510(k) Request to the FDA for DPP SARS-CoV-2 Antigen test system. Shares down 1.7% premarket at $1.73. Chembio received an award from the BARDA to support development of a COVID-19 point-of-care antigen test system using its proprietary Dual Path Platform (DPP) technology. BARDA support included funding for the completion of clinical studies and preparation of a De Novo/510(k) submission for the rapid antigen test system. The DPP SARS-CoV-2 Antigen test system is designed to detect SARS-CoV-2 antigens in only 20 minutes, using a minimally invasive nasal swab and read with a DPP Micro Reader or DPP Micro Reader 2 optical analyzer.

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Chembio Diagnostics submits 510(k) request to FDA for DPP SARS-CoV-2 Antigen test